NUELIN

What it is

Nuelin contains theophylline. Nuelin-SR Tablets are available in sustained release formulations containing 200 mg, 250 mg or 300 mg anhydrous theophylline. Nuelin Syrup contains 133.3 mg anhydrous theophylline per 25 mL in immediate release form.

Approved indications

— Relief and prophylaxis of reversible bronchospasm associated with bronchial asthma. — Relief and prophylaxis of reversible bronchospasm associated with bronchitis. — Relief and prophylaxis of reversible bronchospasm associated with emphysema and related conditions.

Dosing overview

Desirable therapeutic levels are considered to be between 10–20 µg/mL (55–110 µmol/L). **Nuelin-SR Tablets** Adults: 200 to 300 mg (one tablet) every twelve hours, which can be gradually increased or decreased by half a tablet if sufficient therapeutic effect is not achieved or if side effects occur. Nuelin-SR Tablets are not recommended for children under 2 years of age; for children over 2 years, administration as advised by the physician, with the daily dose adjusted according to bodyweight, usually on the basis of up to 10 mg/kg bodyweight every twelve hours. In patients aged over 65 years theophylline clearance is decreased by approximately 25%. **Nuelin Syrup** For children aged 2–4 years (12–16 kg): 10–15 mL every 6 hours; children aged 4–6 years (16–20 kg): 15–20 mL every 6 hours; children aged 6–12 years (20–41 kg): 20–25 mL every 6 hours; adults and children over 12 years (over 41 kg): 25 mL every 6 hours.

Key safety warnings

Sustained release products are therapeutically inappropriate for acute asthma requiring prompt treatment. Theophylline should be used with caution in patients with cardiac arrhythmias, coronary artery disease, unstable angina, cardiomyopathy and severe hypertension because of its cardiac side effects. Theophylline increases gastric acid secretion and should be used with caution in patients with peptic ulcer or gastro-oesophageal reflux. The most common adverse reactions are gastric irritation, nausea, vomiting, anorexia, epigastric pain, reactivation of peptic ulcer, gastro-oesophageal reflux, haematemesis, tachycardia, palpitation, headache, CNS stimulation, reflex hyperexcitability, insomnia and tremor. Other possible reactions include diarrhoea, extrasystoles, flushing, hypotension, tachypnoea, potentiation of diuresis, albuminuria, haematuria, rash, hyperglycaemia, hypokalaemia, alopecia and inappropriate ADH secretion (high dose). More serious signs of high serum levels (usually above 30 µg/mL), such as cardiac arrhythmias and convulsions, may appear rarely without prior warning.

Contraindications

Nuelin-SR Tablets and Nuelin Syrup should not be used where hypersensitivity to its constituents or to xanthines generally is known or has been demonstrated.

PBS listing

Nuelin Syrup 133.3 mg per 25 mL in 500 mL bottles is listed on the PBS as one item with unrestricted supply at an ex-manufacturer price of A$4.45.

Regulatory history

Nuelin Syrup was first listed on the ARTG on 4 July 1991. Nuelin SR 250 was first listed on the ARTG on 11 August 1993. Nuelin SR 200 and Nuelin SR 300 were first listed on the ARTG on 16 May 1997.